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MR-IM Femoral Locking Screw
EUDAMEDClass IIb (EU MDR)
Ref F14FB-PA00543Ref F14FB-PA00545Ref F14FB-PA00560Ref F14FB-PA00561Ref F14FB-PA00553Ref F14FB-PA00551Ref F14FB-PA00538Ref F14FB-PA00563Ref F14FB-PA00540Ref F14FB-PA00559Ref F14FB-PA00556Ref F14FB-PA00555Ref F14FB-PA00554Ref F14FB-PA00541Ref F14FB-PA00549
Identity
- Trade Name
- MR-IM Femoral Locking Screw EUDAMED
- Device Name
- Non-sterile Intramedullary Nailing Systems EUDAMED
- Model / Reference
- F14FB-PA00543 EUDAMEDF14FB-PA00545 EUDAMEDF14FB-PA00560 EUDAMEDF14FB-PA00561 EUDAMEDF14FB-PA00553 EUDAMEDF14FB-PA00551 EUDAMEDF14FB-PA00538 EUDAMEDF14FB-PA00563 EUDAMEDF14FB-PA00540 EUDAMEDF14FB-PA00559 EUDAMEDF14FB-PA00556 EUDAMEDF14FB-PA00555 EUDAMEDF14FB-PA00554 EUDAMEDF14FB-PA00541 EUDAMEDF14FB-PA00549 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934635754547 EUDAMED06934635754523 EUDAMED06934635754370 EUDAMED06934635754363 EUDAMED06934635754448 EUDAMED06934635754462 EUDAMED06934635754592 EUDAMED06934635754349 EUDAMED06934635754578 EUDAMED06934635754387 EUDAMED06934635754417 EUDAMED06934635754424 EUDAMED06934635754431 EUDAMED06934635754561 EUDAMED06934635754486 EUDAMED
- Basic UDI-DI
- B-06934635754547 EUDAMEDB-06934635754523 EUDAMEDB-06934635754370 EUDAMEDB-06934635754363 EUDAMEDB-06934635754448 EUDAMEDB-06934635754462 EUDAMEDB-06934635754592 EUDAMEDB-06934635754349 EUDAMEDB-06934635754578 EUDAMEDB-06934635754387 EUDAMEDB-06934635754417 EUDAMEDB-06934635754424 EUDAMEDB-06934635754431 EUDAMEDB-06934635754561 EUDAMEDB-06934635754486 EUDAMED
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Arthrodesis intramedullary nail, non-distracting
MR-IM Femoral Locking Screw by Wuhan Mindray Scientific Co., Ltd. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
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- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
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- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06934635754547 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Wuhan Mindray Scientific Co., Ltd.
- EUDAMED SRN
- CN-MF-000032692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (15)
- EUDAMED 1fa4a034-bbc0-4695-aec8-0bf553a71925 61 fields · synced Aug 4, 2026
- EUDAMED 304f52dc-c0ce-48af-8dd4-95607b041175 61 fields · synced May 16, 2026
- EUDAMED 8fc95b86-ab9c-469b-8ddc-fcb41f2c22b0 61 fields · synced May 16, 2026
- EUDAMED 734a19d2-2d7a-4dba-8795-b16edea8d645 61 fields · synced May 16, 2026
- EUDAMED 21514d81-3ccc-4613-b3f3-8d218b77618e 61 fields · synced May 17, 2026
- EUDAMED fb7cb9c9-aa94-41d3-bd52-f5a161c20729 61 fields · synced May 17, 2026
- EUDAMED 2bec1027-bdda-4f3c-aab6-56976f134ffa 61 fields · synced May 17, 2026
- EUDAMED a52f01a2-6a6e-46e5-8f56-51f80a978f0e 61 fields · synced May 18, 2026
- EUDAMED f7a79750-1898-420b-9566-de341ab6f24b 61 fields · synced May 18, 2026
- EUDAMED 578ac04c-89a8-4c5b-ad27-bf4faaba9cf0 61 fields · synced May 18, 2026
- EUDAMED 6081a046-dfff-4982-8e8b-7df847e9bebb 61 fields · synced May 18, 2026
- EUDAMED 1f4810f0-7de7-4623-a165-94760e36b9c4 61 fields · synced May 18, 2026
- EUDAMED 803825aa-2768-4c03-bcfa-0d4003ace0d0 61 fields · synced May 18, 2026
- EUDAMED 63efa54a-8fa9-41d6-b0b3-682807c91279 61 fields · synced May 19, 2026
- EUDAMED 436465f1-c5d2-48b8-bf6c-6d9105440ac3 61 fields · synced May 19, 2026